A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas

Advanced Solid Tumor Clinical Trial

Official title: A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of PRT811 in Subjects With Advanced Solid Tumors, CNS Lymphoma, and Recurrent High-Grade Gliomas

Status Completed

Clinical Trial Summary

This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers and high-grade gliomas who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811.

Clinical Trial Description

This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of PRT811, a PRMT5 inhibitor, in subjects with advanced cancers without any approved or available treatment options including solid tumors, CNS lymphoma, and /or high-grade gliomas. The study will consist of 2 parts, a dose escalation part evaluating subjects with advanced solid tumors, CNS lymphoma, and/or high-grade glioma and a cohort expansion part which will evaluate the safety and efficacy of PRT811 in subjects with advanced solid tumors, and glioblastoma multiforme. For subjects, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT811. ;

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Glioma
• Recurrent Glioma

• NCT number: NCT04089449
• Study type: Interventional
• Source: Prelude Therapeutics
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2019
• Completion date: March 28, 2023